Vacuum bandage packing

ABSTRACT

A vacuum bandage is provided for use with a wound having a wound surface. The bandage is connectable to a vacuum source and includes a wound dressing member having a wound contacting surface, a top surface, and a port configured for communication with the vacuum source. The wound dressing member further includes holes in the wound contacting surface configured for communication with the wound surface of the wound and a passageway between the port and each hole. The vacuum bandage further includes a pack adjacent to the top surface of the member. The pack may include an aperture positioned about the port.

This application is a Continuation of U.S. patent application Ser. No.12/328,531 filed Dec. 4, 2008, which is a Continuation of U.S. patentapplication Ser. No. 10/495,908 filed May 19, 2004, which is a U.S.national counterpart application of International Application Serial No.PCT/US02/041229 filed Dec. 20, 2002, which claims the benefit of U.S.Provisional Application Ser. No. 60/344,589 filed Dec. 26, 2001, thedisclosures of each of which are expressly incorporated by referenceherein.

BACKGROUND OF THE INVENTION

The present disclosure relates to packing for placement over a chronicwound, and particularly to packing for use with a vacuum bandage coupledto a vacuum source.

Gauze or commercially available foam packing is typically used to pack awound. One example is the ALLEVYN® Cavity Wound Dressing available fromSmith & Nephew. This particular wound dressing is made of a polyurethanefoam. Gauze is often used to absorb liquid and exudate present on thewound surface.

SUMMARY OF THE INVENTION

The present invention comprises one or more of the following features orcombinations thereof:

The present invention comprises one or more of the following features orcombinations thereof:

A bandage for use with a wound and a vacuum source is provided. Thebandage comprises a wound dressing member having a wound contactingsurface and a port configured for communication with the vacuum source.The member further includes holes formed in the wound contacting surfaceand configured for communication with a wound surface of the wound. Themember includes a passageway between the port and each hole. Thecombination may further include a pack coupled to the top surface of themember. The pack may illustratively include an aperture positioned aboutthe port of the member. A connecter of the member may be received withinthe aperture.

In illustrative embodiments, the pack further includes a bottom surface,a top surface, a side wall extending from the top surface to the bottomsurface, and a slit in communication with the aperture. The slit isdefined by first and second confronting interior surfaces which eachextend from the top surface of the pack to the bottom surface and fromthe aperture to the side wall. The illustrative pack further includes anadhesive layer coupled to the bottom surface of the pack for couplingthe pack to the top surface of the member. The pack may be made ofeither open-celled or closed-cell foam.

The member may be generally non-compressible and made of a medical gradesilicone. The member may further include a connecter coupled to the topsurface of the member. Such a connecter may be received within theaperture of the pack and configured for communication with the port ofthe member and the vacuum source.

Other features of the disclosure will become apparent to those skilledin the art upon consideration of the following detailed description ofthe preferred embodiments exemplifying the best mode of carrying out thedisclosure as presently perceived.

BRIEF DESCRIPTION OF THE DRAWINGS

The detailed description particularly refers to the accompanying figuresin which:

FIG. 1 is a part perspective, part diagrammatic view of a wound carebandage showing the wound care bandage located on the leg of a patientand coupled to both a vacuum and an irrigation source through the use ofa switch valve;

FIG. 2 is an exploded perspective view of the wound care bandage of FIG.1 showing the bandage positioned above a wound bed and including a woundcontacting layer and a cover which cooperate to form a wound dressingmember for placement within the wound bed, and also showing a foampacking for placement adjacent the cover and a sealing film to cover thefoam packing and member to seal about the wound;

FIG. 3 is a perspective view of the foam packing of the bandage showingthen packing having a central aperture and a slit in communication withthe aperture and further showing the packing having an adhesive bottomsurface for coupling with a top surface of the cover;

FIG. 4 is a sectional view of the bandage showing the member adjacentthe wound, the packing adjacent the cover of the member, and a vacuumtube received within the aperture of the packing for coupling with thecover of the member, and further showing the sealing film positionedover the packing and tube to seal to the patient's healthy skin aboutthe wound;

FIG. 5 is a perspective view showing the foam packing of the bandage,the cover of the member, and a horizontal connecter of the membercoupled to the member to be received within the aperture of the foampacking; and

FIG. 6 is a perspective view showing the foam packing adjacent to thebandage and further showing the horizontal connecter of the memberreceived within the aperture of the packing and showing the vacuum tubecoupled to the connecter and received within the slit of the packing.

DETAILED DESCRIPTION OF THE DRAWINGS

A wound care bandage 10 is provided for use with a vacuum and irrigationsource 12, 14, respectively, as shown in FIG. 1. An illustrative vacuumand irrigation source 12, 14 is disclosed in U.S. Patent Publication No.US 2002/0161317 A1 and U.S. Pat. No. 6,458,109, both of which are ownedby the assignee of the present application and both of which are herebyincorporated herein by reference.

Bandage 10 promotes the healing of a large wound 16 (shown in FIG. 2) byproviding vacuum therapy to the wound 16 to promote blood flow andremove exudate from a wound surface 18 of the wound and by providing forirrigation of the wound 16 with fluids such as saline, for example. Asshown in FIG. 2, wound care bandage 10 comprises a thin, flexible wounddressing member 19. Illustrative wound dressing members are disclosed inU.S. Patent Publication No. US 2002/0082567 A1, which is owned by theassignee of this present application and which is hereby incorporatedherein by reference.

Bandage 10 also includes a foam packing 30 above and adjacent member 19,as shown in FIGS. 2 and 4. Packing 30 rests on member 19 and includes anaperture 32 for receiving a vacuum tube 34. As shown in FIG. 4, one endof vacuum tube 34 is coupled to member 19 and, as shown in FIG. 1, theother end of tube 34 is coupled to vacuum source 12 and/or irrigationsource 14. Bandage 10 further includes a film 40 that is placed overmember 19, packing 30, and tube 34 and that attaches to a patient'shealthy skin 42 around wound 16. Packing 30 occupies a space betweenfilm 40 of bandage 10 and member 19.

Member 19, of bandage 10, is made of a medical grade silicone or othertype of elastomer which is pliable. Two companies, for example, whichmanufacture such medical grade silicone are GE Silicones and NuSilTechnology. It is within the scope of this disclosure, however, toinclude a wound dressing member made of any type of thin, flexiblematerial that is non-porous and non-foam-like. This thin, flexiblematerial is also generally non-absorptive. For example, materials suchas polyvinylchloride (PVC), PVC free of diethylhexylphthalate (DEHP-freePVC), polyurethane, or polyethylene may be used in the manufacture ofmember 19.

Further, member 19 may be molded to include anti-microbial constituents.For example, it is within the scope if this disclosure to impregnatemember 19 with silver ions which are known anti-microbials. Member 19 isalso made of a generally non-adhesive material. Therefore, member 19does not adhere to the wound surface 18. Further, member 19 is solid innature and generally non-compressible. For example, when a negativepressure is applied to member 19, a thickness 20 of member 19, as shownin FIG. 4, remains relatively constant. Further, member 19 is generallytransparent to enable a caregiver to be able to see the wound 16 throughmember 19 when member 19 is placed adjacent to wound surface 18. Thistransparency allows the caregiver to view the progress of the healing ofthe wound 16. Although packing 30 is placed over member 19, thuspreventing a caregiver from viewing the wound surface 18, packing 30 isremovable and replaceable without the need to remove member 19 fromwound surface 18, as is described below. Therefore, the progress of thehealing of wound 16 is viewable through member 19 when the caregiver ishas removed packing 30 from member 19 to replace with a new packing 30.

As shown in FIG. 2, wound dressing member 19 is illustrativelyrectangular in shape. However, it is within the scope of this disclosurefor member 19 to be any suitable shape. Further, member 19 may be cut tofit any size wound 16. Member 19 includes the combination of a woundcontacting layer 22 and a cover 24. Member 19 also includes a connecter26 coupled to cover 24 for communication with vacuum source 12 and/orirrigation source 14. It is also within the scope of this disclosure forconnecter 26 to be formed integrally with cover 24 or to be a separatepiece that is attached to cover 24.

Layer 22 includes a wound contacting surface 50 and an upper or oppositesurface 52. Wound contacting surface 50, or portions thereof, contactsand generally conforms to the wound surface 18. Opposite surface 52includes a central area 54 and a plurality of channels 56 which extendradially away from central area 54, as shown in FIG. 2. Central area 54is recessed relative to the portions of upper surface 52 betweenchannels 56. As shown in FIGS. 2 and 4, channels 56 are open at thesides and ends of member 19. Opposite surface 52 further includesconcentric channels 58. Central area 54 is provided to communicate withvacuum source 12 and irrigation source 14 through a port 60 of cover 24,as described below.

A plurality of radially extending protrusions or bosses 62 arepositioned around central area 54. Bosses 62 are positioned betweencentral area 54 and channels 56, 58, as shown in FIG. 2. Bosses 62prevent central area 54 from collapsing in on port 60 of cover 24 andforming an unwanted seal which would effectively block air flow throughport 60 while suction is applied to bandage 10. Port 60 communicateswith the vacuum source 12 and/or the irrigation source 14 via connecter26 and tube 34, as shown in FIG. 2. As mentioned above, port 60 is incommunication with central area 54 of layer 22.

Illustratively, four bosses 62 are shown in FIG. 2. However, it iswithin the scope of this disclosure to provide any number of bosses 62or the like about central area 54 of layer 22 to prevent central area 54from sealing off port 60 of cover 24 as suction is applied to bandage10. Further, it is within the scope of this disclosure to include a bossor bosses 62 having any shape that prevents central area 54 from sealingoff port 60 when suction is applied to bandage 10.

Connecter 26, as shown in FIGS. 2 and 4, is a tubal port coupled to atop surface 70 of cover 24 and in communication with port 60 of cover24. As mentioned before, it is within the scope of this disclosure forconnecter 26 to be a separate component of member 19 which is coupled tocover 24 or for connecter 26 to be molded integrally with cover 24.Connecter 26 includes a vertical passageway 27. Connecter 26 connectswith tube 34 to provide a vertical tube attachment with respect to port60. Vertical connector 26 is received within aperture 32 of packing 30.As mentioned above, however, it is within the scope of this disclosureto include a member 19 having only layer 22 and cover 24, without aconnecter 26, for example. In such an example, tube 34 couples directlyto cover 24 for direct communication with, port 60. Cover 24 includes abottom surface 68 and top surface 70, as shown in FIG. 2. Bottom surface68 engages opposite surface 52 of layer 22, as shown in FIG. 4.

In some embodiments, member 19 is made by heat sealing opposite surface52 of layer 22 and bottom surface 68 of cover 24 together and by heatsealing connecter 26 to top surface 70 of cover 24. Each of connecter26, cover 24 (or the combination of cover 24 and connecter 26), andlayer 22 may be pre-shaped and formed from semi-cured silicone. Once theconnecter 26, cover 24, and layer 22 are placed together appropriately,the entire member 19 may be heated to heat seal and cure each of thethree components to one another. Alternatively, for example, the cover24 only may be made from semi-cured silicone while the connecter 26 andlayer 22 may be made from fully cured silicone. Once placed together andheated, connecter 26 and layer 22 will heat seal to cover 24. Semi-curedsilicone may be bought and pre-molded from a manufacturer such as NuSilTechnology, for example. Although the method of heat sealing the cover24, connecter 26, and layer 22 to each other is disclosed, it is withinthe scope of this disclosure to form member 19 by coupling layer 22,cover 24, and connector 26 together by another suitable means such asthrough the use of adhesives, for example. Further, it is within thescope of this disclosure to provide a member 19 where cover 24 liesadjacent to, but is not coupled to, layer 22.

As mentioned above, cover 24 is coupled to layer 22 and connecter 26 iscoupled to cover 24 to form member 19. Cover 24 and layer 22 cooperateto form distinct passageways 72 of member 19 (as shown in FIG. 4) whichare defined by channels 56, 58 of layer 22 and bottom surface 68 ofcover 24. Passageways 72 are in communication with central area 54 oflayer 22 and central area 64 of layer 22 is in communication with port60 of cover 24 which is in communication with the vacuum and/orirrigation sources 12, 14 via connecter 26 and tube 34. Therefore,passageways 72 are in communication with the vacuum and/or irrigationsources 12, 14.

Layer 22 includes through holes 74 which extend from channels 56, 58through layer 22 to wound contacting surface 50, as shown in FIG. 2.Holes 74 are distinct and are provided to communicate with channels 56,58 of layer 22. Holes 74 therefore communicate with passageways 72 ofmember 19 and the vacuum and/or irrigation sources 12, 14 as well toallow the suction from the vacuum source 12 and/or the fluid from theirrigation source 14 to reach the wound surface 18 via the holes 74.Illustratively, holes 74 are 0.020 inch (0.508 mm) in diameter and arespaced approximately 0.500 inch (12.700 mm) apart along channels 56, 58of layer 22. It is, however, within the scope of the disclosure toinclude holes having other suitable sized diameters and/or othersuitable spacing that allow for the removal of exudate without clogging.

Illustrative member 19 of bandage 10 includes a smooth wound contactingsurface 50, as shown in FIG. 2. Wound contacting surface 50 may also beribbed, textured, or roughened. By providing member 19 with a ribbed,textured, or roughened surface, a space is created between surface 50 oflayer 22 and wound surface 18. Through holes 74 communicate with thisspace which permits vacuum source 12 to establish a generally uniformlydistributed vacuum or negative pressure to the wound surface 18 to drawblood from the body to the wound surface 18 and to draw exudate from thewound 16 through holes 74, into channels 56, 58 and passageways 72, andout port 60 of cover 24. It is within the scope of this disclosure toinclude other means for providing a space between surface 50 and woundsurface 18 such as providing ribs, protrusions, channels, spacers, etc.

The vacuum or negative pressure which draws blood from the body to thewound surface 18 and draws exudate from the wound 16 up through member19 promotes the healing of wound 16. As wound 16 heals, granulationsform along the wound surface 18. Granulations, therefore, are thereplacement within the wound bed of tissue lost. As the granulationsfill in the wound bed causing the wound 16 to heal, member 19 rides upon the wound surface 18 on top of the granulations which are formed.

Although illustrative bandage 10 includes one central port 60, it iswithin the scope of this disclosure to include multiple ports. In orderto accommodate different sized wounds 16, member 19 may be trimmed tofit a particular wound 16. Further, some embodiments of member 19include scale markings. Scale markings indicate areas where a caregivermay trim member 19 to fit a particular wound 16. Further, the scalemarkings may denote measurement sizes, for example, to permit acaregiver to cut the member 19 to fit a pre-measured wound 16. In orderto accommodate various types and placements of wounds on patients, it iswithin the scope of this disclosure to include a member or members invarious conforming shapes and sizes suitable for treating chronic woundson a patient's heel, abdomen, or sternum, for example.

A switch valve 76 is illustratively provided, as shown in FIG. 1, toallow a user to switch between the use of the vacuum source 12 and theirrigation source 14. It will be appreciated that a mechanism other thanthe switch valve 76 may be used selectively to couple the vacuum sourceor the irrigation source to the bandage. Simple tube clamps, forexample, may be used selectively to open and close the tube set providedwith bandage 10. When valve 76 is switched to operate the vacuum source12, the vacuum suction draws exudate up through the holes 74 andradially inwardly through passageways 72 toward port 60 and finallythrough tube 34.

Vacuum/irrigation tube 34 extends over the edge of packing 30 and outfrom under the edge of the sealing film 40. In use, irrigation source 14delivers liquid through tube 34 and port 60 of cover 24 and intopassageways 72 of member 19. The fluid moves radially out throughpassageways 72 to holes 74. The fluid then moves down through holes 74to impinge on wound surface 18.

As described above, bandage 10 includes foam packing 30. Foam packingincludes a top surface 80 and a bottom surface 82. Illustratively, foampacking 30 is rectangular and sized to match member 19. An adhesive 84may be attached to bottom surface 82, as shown in FIG. 3. In someembodiments, a silicone-based adhesive is provided on bottom surface 82.Packing 30 may be permanently or temporarily affixed to top surface 80of member 19 to act as a cavity filler for bandage 10. For example,chronic wounds, such as wound 16, often create a deep cavity. Foampacking 30 is added on top of member 19 to essentially fill the cavitycreated by the wound. In those embodiments in which packing 30 istemporarily attached to or placed on member 19, packing 30 can beremoved and replaced by a caregiver without the need to replace member19.

As mentioned above, packing 30 includes aperture 32 which extends fromtop surface 80 to bottom surface 82. Illustratively, aperture 30 iscentrally located to receive connecter 26 which is centrally located oncover 24 of member 19. It is within the scope of this disclosure forpacking 30 to have an aperture which is not centrally located providedthat the aperture cooperates with either a connecter of member 19 orwith a port of the cover of member 19. As shown in FIG. 4, connecter 26is received within aperture 32 of packing 30. A portion of vacuum tube34 is also received within aperture 32 and couples with connecter 26.

As shown in FIGS. 2 and 3, packing 30 further includes a slit 86. Slit86 is defined by first and second confronting interior surfaces 90, 92which each extend from top surface 80 to bottom surface 82 and are eachin communication with aperture 32. Surfaces 90, 92 each further extendfrom aperture 32 to a side wall 88, as shown in FIGS. 2 and 3. Slit 86provides an entryway for tube 34. Slit 86 allows packing 30 to be easilyremoved and replaced from bandage 10 without the need to disconnect tube34 from connecter 26 or port 60. When removing packing 30 from member19, tube 34 is slid through slit 86 from aperture 32 to side wall 88.When placing a new packing 30 on member 19, tube 34 is slid through slit86 from side wall 88 to aperture 32 to rest one end of tube 34 withinaperture 32. Because packing 30 is replaceable separately from member19, member 19 is able to stay in place on wound surface 18 for a longerperiod of time.

In an alternative embodiment shown in FIGS. 5 and 6, a horizontalconnecter 126 is coupled to cover 24. Horizontal connecter 126 includesa vertical passageway 127 connected to a horizontal passageway 129.Horizontal connecter 126 provides for a horizontal attachment for vacuumtube 34, rather than the vertical attachment shown in FIGS. 2 and 4.Horizontal connecter 126 is coupled to cover 24 in the same manner asconnecter 26 and communicates with port 60 of cover 24. When foampacking 30 is coupled to or positioned adjacent to cover 24, as shown inFIG. 6, horizontal member 126 is received within aperture 32 of packing30. Further, tube 34 is received wholly or partially within slit 86 ofpacking when tube 34 is coupled to connecter 126.

It is within the scope of this disclosure for foam packing 30 to beperforated to facilitate customizing the size of the foam to the woundcavity without using scissors. Further, foam packing 30 includesopen-cell or closed-cell types of foam. For example, it is within thescope of this disclosure to include foam packing 30 made of hydrophobicor hydrophilic polyurethane foam or polyvinylalcohol foam.

As mentioned above, bandage 10 includes sealing layer or film 40 that isplaced over packing 30 and around tube 34, as shown in FIGS. 2 and 4.Film 40 may be substantially larger than the wound 16 or member 19 andpacking 30 to provide an effective seal about the member 19 and thewound 16. Film 40 is provided to cover the entire wound 16 and to extendacross and attach around tube 34 to the patient's healthy skin 42, asshown in FIG. 1. Preferably, film 40 is an occlusive or semi-occlusivematerial which allows water vapor to permeate through. Because of thischaracteristic, film 40 is referred to as Moisture Vapor TransmissionRate film or MVTR film. The products TEGADERM® brand sealing film madeby 3M Corporation and OPSITE FLEXIGRID® made by Smith & Nephew can beused for film 40, for example. The product OPSITE FLEXIGRID® is asemi-permeable film. Film 40 is approximately 0.003 inch (0.076 mm)thick, however, it is within the scope of this disclosure to include anocclusive or semi-occlusive film 40 having other thickness. Film 40 isprovided to create a sealed environment below the film 40 and around thewound 16 in which a vacuum or negative pressure can be maintained asprovided by vacuum source 12.

Although this invention has been described in detail with reference tocertain embodiments variations and modifications exist within the scopeand spirit of the invention as described and defined in the followingclaims.

The invention claimed is:
 1. A vacuum bandage connectable to a source offluid and provided for use with a wound having a wound surface, thebandage comprising: a wound dressing member having a wound contactingsurface, a top surface, a port configured for fluid communication withthe source of fluid, holes in the wound contacting surface configuredfor communication with a wound surface of the wound, and a passagewaybetween the port and the holes, and a pack adjacent the top surface ofthe wound dressing member and having an aperture positioned about theport.
 2. The bandage of claim 1, wherein the pack includes a bottomsurface, a top surface, a side wall extending from the top surface tothe bottom surface, and a passage extending from the aperture to the topsurface wall.
 3. The bandage of claim 2, wherein the wound dressingmember further includes a connecter coupled to the top surface of thewound dressing member and in communication with the port of the wounddressing member.
 4. The bandage of claim 1, wherein the pack includes abottom surface, a top surface, a side wall extending from the topsurface to the bottom surface, and a passage extending from the apertureto the side wall.
 5. The bandage of claim 4, wherein the wound dressingmember further includes a connecter coupled to the top side surface ofthe wound dressing member and in communication with the port of thewound dressing member.
 6. The bandage of claim 5, wherein the pack isremovable from the member while the member remains coupled to the vacuumsource.
 7. The bandage of claim 1, wherein the pack is an opened-cellfoam.
 8. The bandage of claim 1, wherein the pack is a closed-cell foam.9. The bandage of claim 1, wherein the source of fluid is a source ofnegative pressure.
 10. The bandage of claim 1, wherein the pack isremovably coupled to the member.
 11. The vacuum bandage of claim 1,wherein the wound dressing member includes an anti-microbial.
 12. Thevacuum bandage of claim 11, wherein the anti-microbial includes silverions.
 13. A vacuum bandage connectable to a source of fluid and providedfor use with a wound having a wound surface, the vacuum bandagecomprising: a wound dressing member having a wound contacting surfaceconfigured to contact the wound, a plurality of holes formed in thewound contacting surface, and a port configured to be coupled to thesource of fluid; a foam pack disposed on the wound dressing member andhaving an aperture about the port of the wound dressing member; a tubereceived in the aperture of the foam pack, the tube having a first endcoupled to the port of the wound dressing member and a second endconfigured to be coupled to the source of fluid; and a sealing filmcovering the tube, the foam pack, and the wound dressing member andconfigured to form a seal over the wound.
 14. The vacuum bandage ofclaim 13, wherein the wound dressing member includes silver ions. 15.The vacuum bandage of claim 14, wherein the wound contacting surfaceincludes silver ions.
 16. A vacuum bandage connectable to a source offluid and provided for use with a wound having a wound surface, thevacuum bandage comprising: a wound contacting layer having a woundcontacting surface configured to engage the wound surface, a topsurface, and holes in the wound contacting surface configured forcommunication with the wound surface; a port configured to be coupled tothe wound contacting layer; a tube having a first end configured to becoupled to the port and a second end configured to be coupled to thesource of fluid; and a pack including an aperture, wherein the pack isdisposed above the wound contacting layer such that the pack ispositioned in fluid communication with the port; wherein the woundcontacting layer includes an anti-microbial.
 17. The vacuum bandage ofclaim 16, wherein the anti-microbial includes silver ions.
 18. Thevacuum bandage of claim 17, wherein the wound contacting surfaceincludes the silver ions such that the silver ions are configured toengage the wound surface.
 19. The vacuum bandage of claim 17, whereinthe silver ions are molded into the wound contacting layer.
 20. Thevacuum bandage of claim 16, wherein the wound contacting layer isflexible in order to conform to the wound surface.
 21. A vacuum bandageconnectable to a source of fluid and provided for use with a woundhaving a wound surface, the vacuum bandage comprising: a woundcontacting layer having a wound contacting surface configured to engagethe wound surface, a top surface, and holes in the wound contactingsurface configured for communication with the wound surface; a portconfigured to be coupled to the wound contacting layer; a tube having afirst end configured to be coupled to the port and a second endconfigured to be coupled to the source of fluid; a pack including anaperture, wherein the pack is configured to be disposed above the woundcontacting layer such that the is positioned in fluid communication withthe port; and a sealing film covering the tube, the pack, and the woundcontacting layer and configured to form a seal over the wound.
 22. Thevacuum bandage of claim 21, wherein the wound dressing member includesan anti-microbial.
 23. The vacuum bandage of claim 22, wherein theanti-microbial includes silver ions.